醫(yī)療器械設(shè)備與CT控制系統(tǒng)特色化設(shè)計(jì)與開發(fā)

1、。The roleoftheU.S.Foodand DrugAdministrationindeviceevaluationandmonitoring政府機(jī)構(gòu)、食品醫(yī)藥研究所對(duì)與醫(yī)療設(shè)備的評(píng)估與監(jiān)控的作用The American Societyfor GastrointestinalEndoscopy (ASGE) Technology Committee providesreviews of existing,new, or emerging endoscopic technologiesthathave an impact on the practiceof GI endoscopy. E

2、vidence-basedmethodology is used by performing a MEDLINE literature search to identify pertinent clinical studies on thetopic and a MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) databasesearch to identify the reported complications of a given technology. Both a

3、re supplemented by accessing the“relatedarticles”featureof PubMedand by scrutinizingpertinentreferencescitedby the identifiedstudies.TechnologyStatus Evaluation Reportsare draftedby 1 or 2 membersoftheASGETechnology Committee,reviewedand editedby the committee as a whole,and approved by the Governin

4、g Board of the ASGE.Whenfinancialguidanceis indicated, the most recent coding data and list prices at the time of publication are provided. For thisreview,the MEDLINEdatabase was searched throughOctober 2009 for articlesand references relatedtodevicesand the U.S. Food and Drug Administration by usin

5、g the keywords“FDA”and “devices. ”In addition, the Web wassearchedusing the same keywords. The U.S. Food and Drug Administrationwebsite was also thoroughlyreviewed.Practitioners should continue to monitor the medical literature for subsequent data about these issues.The electronic medical record as

6、a tool for infection surveillance: Successful automation of device-daysManual collection of central venous catheter, ventilator, and indwelling urinary catheter device-days istime-consuming, often restricted to intensive care units (ICU) and prone to error.MethodsWe describe the use of an electronic

7、 medical record to extract existing clinical documentation of invasivedevices. This allowed automated device-days calculations for device-associated infection surveillance inan acute care setting.。1。ResultsThe automated system had high sensitivity,specificity,and positive and negative predictivevalu

8、es (>0.90)compared with chart review. The system is not restricted to ICUs and reduces surveillance efforts by aconservative estimate of over 3.5 work-weeks per year in our setting. Eighty percent of urinary catheterdays and 50% of central venous catheter-days occurred outside the ICU.ConclusionD

9、evice-days may be automatically extracted from an existing electronic medical record with a higher degreeof accuracy than manual collection while saving valuable personnel resources.A perspective on intelligent devices and environments in medical rehabilitationGlobally, the number of people older th

10、an 65 years is anticipated to double between 1997 and 2025, whileat the same time the number of people with disabilities is growing at a similar rate, which makes technicaladvances and socialpolicies criticalto attain, prolong,and preserve qualityoflife. Recentadvancementsin technology, including co

11、mputation, robotics, machine learning, communication, and miniaturization ofsensors have been used primarily inmanufacturing,military,space exploration,and entertainment. However,few efforts have been made to utilize these technologies to enhance the quality of life of people withdisabilities. This

12、article offers a perspective of future development in seven emerging areas: translationof research intoclinicalpractice,pervasiveassistivetechnology, cognitiveassistivetechnologies,rehabilitation monitoring and coaching technologies, robotic assisted therapy, and personal mobility and manipulation t

13、echnology.智能化醫(yī)療設(shè)備與醫(yī)院就診、住院的適宜性環(huán)境：一個(gè)普通使用者的視角Provision and use of safety-engineered medical devices among home care and hospice nurses in North CarolinaNurses who providecare inthe home are at riskof blood exposure from needlesticks.Using safety-engineeredmedical devices reduces the risk of needlestick

14、. The objectives of this study were to assess provision ofsafetydevicesby homecare and hospice agencies as wellas the use of these devicesby home care and hospicenurses in North Carolina, and to examine the association between provision and use.家用與護(hù)士用醫(yī)療設(shè)備的安全工程應(yīng)用與分類：北加利福尼亞州的經(jīng)驗(yàn)和例子。2。Using ontologies t

15、o integrate and share resuscitation data from diverse medical devicesTo propose a method for standardiseddata representationand demonstratea technologythatmakes itpossibleto translate data from device dependent formats to this standard representation format.Methods and resultsOutcome statisticsvaryb

16、etween emergency medical systems organising resuscitationservices.Such differencesindicate apotential forimprovement byidentifying factors affectingoutcome,but data subject toanalysishave to be comparable.Modern technologyfor communicatinginformationmakes itpossible tostructure, storeand transferdat

17、aflexibly.Ontologiesdescribe entities inthe worldand how they relate.Lettingdifferentcomputer systems refer to the same ontology results in a common understanding on data content. Informationon therapy such as shock delivery, chest compressions and ventilation should be defined and described ina sta

18、ndardised ontology to enable comparison and combining data from diverse sources. By adding rules andlogic data can be merged and combined innew ways to produce new information. An example ontologyis designedto demonstrate the feasibility and value of such a standardised structure.ConclusionsThe prop

19、osed technology makes possible capturing and storing of data from different devicesin astructured and standardised format. Data can easily be transformed to this standardised format, compared and combined independent of the original structure.醫(yī)療設(shè)備的數(shù)據(jù)共享與信息孤島醫(yī)療設(shè)備用管道材料與零部件設(shè)計(jì)Finite element modelling of

20、medical devices。3。A pilot study of key nursing aspects with different cooling methods and devices in the ICUTherapeutichypothermia(TH) has become an integratedpartof neurointensivecare.Still,littledata existson the actual experience with cooling patients in the ICU from the intensive care nurse (ICN

21、) perspective.The purpose of thissurvey was to evaluateimportantnursingaspects with differentcoolingmethods and devicesin ICU use.Materials and methodsThe ICNs used a four-point rating scale (1= worst, 4= best possible) to evaluate (a) ease of application,(b)visual patientmonitoring,(c)work load, (d

22、)hygiene and (e)noise level withfour cooling methodsusedin our ICU. Our simple, initial method of towels soaked in iced water spread over the torso was comparedto three commercial cooling methods used; (1) Coolgard 3000 (Alsius, Irvine, USA), (2) Thermowrap (MTRE,Yavne, Israel) and (3) Artic Sun (Me

23、divance, Louisville, USA).ResultThere were significantdifferencesin how the ICNs ratedthe nursingaspects of the differentcoolingmethods.Ice-water soaked towels over the torso scored high with respect to ease of application and noise level. Forwork-load,allthe three commercial devices scored signific

24、antlybetterthan ice-watersoaked towels ( P < 0.05).Only the Coolgard 3000 system scored significantly better than ice-water soaked towels for visual patientmonitoring (P< 0.001). For hygienic aspects, Artic Sun and Coolgard scored significantly higher than theothers (P< 0.05). Overall, the

25、ICNs involved felt they had a general good understanding of TH but were onlypartly prepared in terms of training and knowledge of protocols and complications when TH was introducedin our ICU. The majority felt the new cooling protocol was acceptable.ConclusionWeidentifiedsignificantdifferencesin the

26、 ratingof key nursingaspects of the differentcoolingmethods.More studies on implementation of new cooling methods and devices seem warranted.。4。CleaningefficacyofmedicaldevicewashersinNorthAmericanhealthcarefacilitiesThe objective of this study was to determine the worst case levels of organic soil

27、on surgical instrumentsand whether the commercially availableTOSI? provided a clinicallyrelevantorganicchallenge to an instrumentwasher. Our data showed that protein and haemoglobin levels (374 and 111g/cm2, respectively) from theinstruments evaluated correlated with those on a TOSI that had a visua

28、l score of 23 (267 and 60g/cm2,respectively). However, the regular TOSI (without the plastic cover) and the TOSI Lum-Chek do not presentdifficultcleaningchallenges;therefore,a visualTOSI scoreof15 afterprocessing inan automated washerrepresentsa seriouscleaningproblem.Ourresultsshowedthatsurgical in

29、strumentsmay have highpost-cleaning levels of carbohydrate (up to 352g/cm2) and endotoxin(up to25 373 EU/cm2), suggestingunrecognised issueswith the qualityof water used for the finalrinse.The averagecarbohydrateand endotoxinlevels post procedureand beforecleaningwere 138.9 g/cm22The averageproteina

30、nd 18.14 EU/cm, respectively.and haemoglobin levelsboth showed >99%reductioninlevelspost cleaning.Our datasupportthe need tomonitorthe water quality used in instrument washers. In addition, there is an urgent need for establishment ofstandardised criteria for rapid cleaning indicators for instrum

31、ent washers to ensure that they provide aclinically relevant method for monitoring washers used in healthcare facilities.Trends in tubal sterilization and intrauterine device uptake at an urban academic medical centerPoly(glycerol-dodecanoate), a biodegradable polyester for medical devices and tissu

32、e engineering scaffoldsIn this paper we describe the mechanical and biological features of a thermosetting polyester synthesized from glycerol and dodecanedioic acid named Poly-Glycerol-Dodecanoate (PGD). This polymer shows a glasstransitiontemperature( Tg) around 32 °C, and thisaccounts for it

33、smechanical properties.At room temperature(21 °) PGDbehaves likea stiffelastic-plasticmaterial,while at body temperature(37 °C), itshows a compliantnon-linear elastic behavior. Together with biodegradability and biocompatibility PGD has distinct shapememory features. After the polymer is c

34、ured, no matter what the final configuration is, we can recover theoriginal shape by heating PGD to temperatures of 32°C and higher. The mechanical properties together withbiocompatibility/biodegradability and shape memory features make PGD an attractive polymer for biomedical applications.Vent

35、ricular Assist Devices: The Challenges of Outpatient ManagementThe need for mechanical assistance of the failing heart, whether acute after a myocardial infarction orpermanent in patients with end-stage heart failure, has increased with improvements in medical therapy anda growing aged population. O

36、ver the past few decades, much progress has been made in the development and。5。refinement of ventricular assist devices (VADs), medical devices capable of maintaining circulatory outputof the diseased ventricle. Initially designed as a temporary support to allow ventricular recovery or asa bridge fo

37、r patients to cardiac transplantation, these devices are now being used as a permanent form of“destination”therapy.Improvements in technologicaldesign,durability,and medical managementhave allowedindividualswith VADsto be managedin theircommunities.Although these devices provideexcellenthemodynamics

38、upport and enhance patient functional status, discharged individuals face many unique challenges. In thisarticle, we discuss 1) the spectrum of VADs for outpatient therapy, including their basic physiology andhemodynamics; 2) the multidisciplinary approach required to care for a patient with such a

39、device in thecommunity; 3) routine general cardiac issues that are encountered; 4) associated long-term device andnondevice-related complications; and 5) the reported overall improvements in quality of life.醫(yī)用輔助裝置與設(shè)備：管理與外出使用時(shí)的維護(hù)Comparison of Medical Treatment in Outpatients Receiving Device Therapy

40、for Systolic Dysfunction: A Report from IMPROVE HFDevelopment of a Hybrid Decision Support Model for Optimal Ventricular Assist Device WeaningDespite the small but promising body of evidence for cardiac recovery in patients that have receivedventricular assist device (VAD) support, the criteria for

41、identifying and selecting candidates who mightbe weaned from a VAD have not been established.MethodsA clinical decision support system was developed based on a Bayesian Belief Network that combined expertknowledge withmultivariatestatisticalanalysis.Expert knowledge was derived from interviews of11

42、membersof the Artificial Heart Program at the University of Pittsburgh Medical Center. This was supplemented byretrospectiveclinical datafrom the19 VADpatientsconsidered for weaning between 1996 and 2004. ArtificialNeural Networks and NaturalLanguage Processing were used to mine these data and extra

43、ct sensitivevariables.Results。6。Three decision support models were compared. The model exclusively based on expert-derived knowledge wasthe least accurate and most conservative. It underestimated the incidence of heart recovery, incorrectlyidentifying 4 of the successfully weaned patients as transpl

44、ant candidates. The model derived exclusivelyfrom clinical data performed better but misidentified 2 patients: 1 weaned successfully, and 1 that neededa cardiactransplantultimately.An expert-datahybridmodel performed best,with 94.74% accuracy and 75.37%to 99.07% confidence interval, misidentifying o

45、nly 1 patient weaned from support.ConclusionsA clinical decision support system may facilitate and improve the identification of VAD patients who arecandidates for cardiac recovery and may benefit from VAD removal. It could be potentially used to translatesuccess of active centers to those less established a